Step S101000

GUDID 10884521090705

Radially Expandable Sleeve

Covidien LP

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use

• Primary Device ID: 10884521090705
• NIH Device Record Key: c0f531df-21f1-459c-a401-6406266aa7ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Step
• Version Model Number: S101000
• Catalog Number: S101000
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521090705 [Package]; Contains: 20884521090702; Package: CASE [10 Units]; In Commercial Distribution
GS1	20884521090702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961940

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-24

On-Brand Devices [Step]

• 10884521090842: Insufflation Needle
• 10884521090828: Insufflation Needle
• 10884521090798: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090767: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090736: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090705: Radially Expandable Sleeve
• 10884521090675: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090668: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090651: Dilator and Cannula with Radially Expandable Sleeve
• 10884521090644: Short Radially Expandable Sleeve